Enhanced Medical Rehabilitation (EMR) for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan Ability Lab, Chicago, IL
Spinal Cord Injuries+1 More
Enhanced Medical Rehabilitation (EMR) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

To achieve higher levels of patient engagement, it is important to improve therapists' techniques for goal setting and clinician-therapist communication. Thus, the investigators have developed a manualized intervention for post-acute rehabilitation, Enhanced Medical Rehabilitation (EMR), which is an evidence-based program to increase patient engagement and achieve a greater intensity of therapy, thereby optimizing the patient's functional and psychosocial recovery. EMR is an integrated set of skills for occupational and physical therapists that transform rehabilitation through (1) a patient-directed, interactive approach; (2) increased treatment intensity; and (3) frequent feedback to patients on effort and progress. The investigators have developed training and supervision methods to enable therapists to carry out these skills with high fidelity. Due to the complexity of the inpatient spinal cord injury (SCI) rehabilitation environment, it is unknown whether the EMR program will be clinically relevant to inpatient rehabilitation settings and acceptable to SCI populations. Therefore, it is necessary to conduct a systematic adaptation approach to address all barriers, and test this adapted program to a new setting (inpatient rehabilitation) and a new population (patients with SCI), without compromising the core elements of the original EMR. Objective: The investigators propose to adopt the EMR program for use in inpatient SCI rehabilitation settings using an implementation science. The investigators propose a randomized trial of 80 patients with SCI to test the effects of EMR on improving engagement and treatment intensity, as well as functional and psychosocial outcomes over standard of care (SOC) rehabilitation. Methods: The investigators will randomize patients into EMR or SOC groups. For the EMR group, four therapists will be trained and supervised in EMR and will incorporate EMR techniques into therapy sessions. In the SOC group, four therapists will carry out therapy sessions as usual. Outcomes: With respect to EMR intervention adaptions, the investigators hypothesize that the EMR program, including a treatment manual and other materials, will be customized with input from our Spinal Cord Injury-Community Advisory Board (SCI-CAB). Patients randomized to EMR will have greater engagement and intensity and greater functional and psychosocial recovery compared to those randomized to SOC rehabilitation. Significance: Success in this research will improve therapists' skills working with patients and optimizing patient outcomes

Eligible Conditions

  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 1 month

1 month
Adherence/Fidelity: Change in Patient Satisfaction & Treatment Fidelity Survey
Adherence/Fidelity: Change in Therapist Adherence Rating Form
Depression: Change in Patient Health Questionnaire-9
Function: Change in Continuity Assessment Record and Evaluation
Life Satisfaction: Change in Satisfaction with Life Scale
Patient Participation/Engagement: Change in Pittsburg Rehabilitation Participation Scale (PRPS)
Patient-Clinician Interaction: Change in Clinical Assessment of Modes Observer Form (CAM-O)
Patient-Clinician Interaction: Change in Clinical Assessment of Suboptimal Interactions Short Forms (CASI-O-15)
Rehabilitation Intensity: Change in ActiGraph
Rehabilitation Intensity: Change in Patient Active Time
Work Alliance: Change in Working Alliance/Theory of Change Inventory (WATOCI)
the first two weeks during patient rehabilitation stay
Baseline Comorbidity: Charlson Comorbidity Index
the last week during patient rehabilitation stay
Post-intervention Satisfaction: Modified Treatment Satisfaction Questionnaire

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care (SOC)
1 of 2
Enhanced Medical Rehabilitation (EMR)
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced Medical Rehabilitation (EMR) · No Placebo Group · N/A

Enhanced Medical Rehabilitation (EMR)
Behavioral
Experimental Group · 1 Intervention: Enhanced Medical Rehabilitation (EMR) · Intervention Types: Behavioral
Standard of Care (SOC)NoIntervention Group · 1 Intervention: Standard of Care (SOC) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Closest Location: Shirley Ryan Ability Lab · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2018First Recorded Clinical Trial
3 TrialsResearching Spinal Cord Injuries
7 CompletedClinical Trials

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
167 Previous Clinical Trials
13,084 Total Patients Enrolled
46 Trials studying Spinal Cord Injuries
4,585 Patients Enrolled for Spinal Cord Injuries
Washington University School of MedicineOTHER
1,772 Previous Clinical Trials
2,270,601 Total Patients Enrolled
19 Trials studying Spinal Cord Injuries
907 Patients Enrolled for Spinal Cord Injuries
Piper Hansen, OTDStudy DirectorShirley Ryan Ability Lab
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Spinal Cord Injuries
80 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a licensed therapist specializing in SCI patients.
You are willing and able to participate in EMR training and supervision sessions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References